iCAD Corporate PresentationCertain statements contained in this presentation constitute...

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iCAD Corporate Presentation NASDAQ: ICAD March 2020

Transcript of iCAD Corporate PresentationCertain statements contained in this presentation constitute...

Page 1: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

iCAD Corporate PresentationNASDAQ: ICAD

March 2020

Page 2: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Safe Harbor Statement

Certain statements contained in this presentation constitute “forward-looking statements” within the meaning ofthe Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of knownand unknown risks, uncertainties and other factors which may cause the actual results, performance orachievements of the Company to be materially different from any future results, performance or achievementsexpressed or implied by such forward-looking statements. Such factors include, but are not limited to theCompany’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks ofuncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertaintyof future sales levels, protection of patents and other proprietary rights, product market acceptance, possibletechnological obsolescence of products, increased competition, litigation and/or government regulation, changesin Medicare or other reimbursement policies, risks relating to our existing and future debt obligations,competitive factors, the effects of a decline in the economy or markets served by the Company; and other risksdetailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”,“demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”,“anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautionednot to place undue reliance on those forward-looking statements, which speak only as of the date the statementwas made. The Company is under no obligation to provide any updates to any information contained in thisrelease. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosurecontained in our Annual Report or Form 10-K for the fiscal year ended December 31, 2018 filed with theSecurities and Exchange Commission on March 29, 2019.

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Page 3: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Breakthrough Radiation Therapy – eBxRevolutionary Clinical AI Technology

iCAD: Two Core Technologies, Multiple Clinical Applications

Discovery • 1st to market with innovative software for 3D

mammography

• Breakthrough FDA claims in clinical performance & workflow

• Large installed base – 4,000+ customers globally

• Strong Partnerships

• Imaging OEMs

• PACS

• Platform expandable to other clinical applications

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Recovery• Unique electronic brachytherapy platform

• FDA cleared, CE marked, & licensed OUS number; treatment anywhere in the body

• Core applications include:

• --Breast cancer

--Gynecological cancers

--Rectal and Neuro Cancers

--Prostate cancer (breakout potential)

• Aligned with emerging bundled & value-based healthcare initiatives

Page 4: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

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▪ Risk Factors

▪ Relatives with breast cancer

▪ Breast density

▪ Benign breast biopsy

▪ Race/ethnicity

▪ Menopausal status

▪ Menopausal hormone therapy

▪ Oral contraceptives

▪ Body mass index

▪ Months since last examination

Analog Mammography

Digital 2D Mammography

3D Tomosynthesis

Future-

Predictive Analytics

4th Generation AI Correlated Data - Cloud Based

Future-

Cloud Based AI

Partnership with Karolinska Institute- 70K Patient

Software as a Medical Device- FDA Label

2020 Release with 300% more images

Built on world’s largest dataset of AI Breast Images

Creating World’s 1st Radiomic, Genomic & Risk Factor Al Capability

Focused on accelerating adoption and building a4th Generation AI capability for the future

Page 5: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

From 4 images to 300 images

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Page 6: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Detection BusinessUnits, Total Available Market and Served Market

3D Tomosynthesis Market (units)

Initial Focus36,000 WW TAM

18,000

US TAM

9500

Installed 3D Units

$30,000

ASP

$3000

Service

$ Market Size

$1.2B WW TAM

$600M

US TAM

$315M

Served Market

Served Market growing at 500 new 3D units/quarter6

Page 7: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Clinical & Business Challenges Solved by ProFound AI

• Reading over 30,000 mammograms annually

• Volume of DBT cases/number of images per case

• Courtesy of Dr. Randy Hicks, MD. MBA, CEO RMI Michigan (10 sites)

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Study # of Screening

Studies

Images/4 View Study

Total Images/Day

In One Week In 200 Day Year

2D 100 4 400 2,000 80,000

DBT 100 280 28,000 140,000 5,600,000

2.9 Days of 3D DBT reading equivalent to a years worth of 2D readingProFound AI reduced unnecessary call backs 30%

Page 8: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Find the soccer ball among the panda bears -- 1mm slices without PFAI

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Page 9: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Find the soccer ball among the panda bears -- 1mm slices with PFAI

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Page 10: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Individual Reader Performance without ProFound AI

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• Wide variability in reader performance reading without AI– Sensitivity/Specificity: location of circle for

each reader

– Reading Time: size of circle

• AI operating point on enriched reader study dataset– High Case-level Sensitivity

– High Specificity (hard to achieve both)

• AI sensitivity higher than 22 of 24 readers without AI

• AI specificity lower than 20 of 24 readers without AI

ProFound AI standalone performance

Page 11: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Individual Reader Performance with ProFound AI

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ProFound AI standalone performance

• Less variability in reader performance reading with AI

➢ Move together

• Improved sensitivity with AI for readers with high specificity without AI

➢ Move up

• Improved specificity with AI for readers with high sensitivity without AI

➢ Move to left

• Improved reading time with AI for readers with high sensitivity and high specificity without AI

15% misread cases before ProFound AI8% were missed without ProFound AI and 7% were unnecessarily called back

FDA results: 8% increased sensitivity, 7% fewer call backs. 52.8% reduced reading time, 58% for complex breast cases.

Page 12: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

ProFound AI Doubles Detection Capability over 2D

2D

3D 3D w/ ProFound AI

AUC: 5.9% • Superior Specificity• Non-Inferior Sensitivity

• Superior Sensitivity• Superior Specificity• Superior Reading Time

AUC: 5.7% GE Reader Study Claims iCAD Reader Study Claims

5.9% in AUC

2D

11.6% with 3D plus ProFound AI Doubles Detection Performance at fraction of the price

5.7% in AUC

$300,000 ASP $30,000 ASP

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Page 13: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Major Cost Avoidance

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This alone leads to breakeven on a $30K license in just weeks and major cost avoidance over years… plus improved detection performance.

Page 14: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

ProFound AI Channel Success

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OEMs / Key Customer

GE Hologic

Siemens Fuji

Several enterprise-level customers with mixed OEM environments

Page 15: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

ProFound AI Channel Success Cont’d

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PACs & Mammo Workstations National Accounts

Page 16: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Focused on accelerating adoption and building a4th Generation AI capability for the future

▪ Risk Factors

▪ Relatives with breast cancer

▪ Breast density

▪ Benign breast biopsy

▪ Race/ethnicity

▪ Menopausal status

▪ Menopausal hormone therapy

▪ Oral contraceptives

▪ Body mass index

▪ Months since last examination

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Analog Mammography

Digital 2D Mammography

3D Tomosynthesis

Future-

Predictive Analytics

4th Generation AI Correlated Data - Cloud Based

Future-

Cloud Based AI

Partnership with Karolinska Institute- 70K Patient

Software as a Medical Device- FDA Label

2020 Release with 300% more images

Built on world’s largest dataset of AI Breast Images

Creating World’s 1st Radiomic, Genomic & Risk Factor Al Capability

Risk Factors

60%

Risk Factors + AI Panorama

77%

Goal80% +

Page 17: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Our Vision is Panoramic

Solution examine the full picture including prior images* (3D & 2D) current image detection & short-term prospective individual risk*

Mapping a unique & personalized patient journey

(*Not yet commercially available.)

Current(Present)

Prospect*

(Future)Priors*

(Past)

Page 18: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

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Evolution of iCAD’s AI Technology from Detection to Prediction… with Panorama

50%Certainty

Score

Compared to =

69%AdjustedCertainty

Score

Short-Term Image-Based Risk Factors

50%Certainty

2020

30%Certainty

2019

17%Certainty

2018

69%AdjustedCertainty

Score=

Panorama will transform age-based screening to deliver risk-adjusted personalized detection

Compared to

Today

Future Personalized Risk Prospect Score

Compared to

+

=

You Today Your History Your Future =+ Panorama

Single Mammo Image Millions of Images

91%

27%

Personalized Risk Prospect Score

Page 19: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Now

So ProFound Panorama will not only will tell you where you are now….

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Page 20: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Now

Where From Where To

Priors & Prospect will tell you where you’ve come from and where you’re heading

Our Vision is Panoramic

Page 21: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Innovative Radiation Therapy Platform

• Targeted, X-ray technology expands highly-focused treatment options for a range of cancers in a variety of medical settings

• Significant cost, mobility and treatment time advantages

• FDA cleared, CE marked and licensed in a growing number of countries for treatment anywhere in the body

• Core applications include breast, non-melanoma skin cancer, and GYN cancers

• Growing body of IORT clinical evidence with ~5 year follow up data with similar recurrence to 6 weeks of radiation therapy

• Excellent outcomes and superior cosmetic results compared to alternative treatments

• Substantial growth opportunities with expanded market share, additional applications and international expansion

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Xoft Electronic Brachytherapy (eBx) System

Proprietary, miniaturized X-ray source

Highly-mobile controller

Balloon applicators (breast)

Surface applicators (skin)

GYN applicators

Page 22: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Xoft Core Technology & Platform

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Products

System of Care

Core Technology

Plan – Treat – Verify

• World’s smallest therapeutic x-ray source

• Similar business core technologies that led to extensive value creation:• Cryo Ablation• RF Ablation• Laser Frequency Ablation

Page 23: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Xoft has a clear growth trajectoryAccelerating new product offerings based on market-driven feedback

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Prostate

GYN

Breast

Neuro/Brain

Growth bolstered by new clinical data and emerging applications

Center of InfluencePhysicians

Rectal

Page 24: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

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Evolving the Business Model

Brain Cancer

Breast Cancer

GI Cancer

GYN

Cancer

Prostate Cancer

Radiation Oncologist

Center of Influence Physician

Cancer Patients

Clinical Study

Hospital Admin

Advising Rad Onc

Physicist

Commercialization approach has shifted from a push-based model dependent upon the Rad Onc, to a pull-based model centered around a Center of Influence

Center of Influence is the epicenter of gatekeeper physicians, patient activation, and clinical innovation.CPT codes are now an accelerant – our business does not depend on them.

PUSH PULL

Page 25: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Recurrent GBM – Presented at EANS 2019 by European Medical Center, Moscow

30 patients treated at 2 institutions between August 2016 and September 2019

Matched Pair Study: Group A: (15 Patients) Xoft IORT 20 Gy - Group B: (15 Patients) External Beam Radiotherapy

Median Overall Survival24 months

(range 13.5-48.5 months)

Median Overall Survival21 months

(range 5.5 – 38.5 months)

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159 of 15 patients in Group A were still

alive with no local recurrence0 of 15 patients were still alive

in Group B

0123456789

101112131415

0 5 10 15 20 25 30 35 40

Nu

mb

er o

f P

atie

nts

Months Following Surgery

Survival and Disease-Free Survival

Disease-Free Survival - Xoft

0123456789

101112131415

0 5 10 15 20 25 30 35 40

Nu

mb

er o

f P

atie

nts

Months Following Surgery

Survival and Disease-Free Survival

Disease-Free Survival - Control

12 Months16 Months

9.5 Months

3.5 Months

Page 26: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

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Xoft Reimbursement Update

Rad Onc APM/RO OPPS APM/Hospital

Breast IORT $503 $2,074 $7,942 $9,740

Prostate IORT $503 $3,228 $7,942 $19,852

Rectal IORT $503 $2,369 $7,942 $11,589

Page 27: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

APM Provider Financial Impact

• New bundled model incentivizes provider selection of cost-effective treatment

• Xoft single patient encounter vs. multiple fraction delivery attractive to providers

CMS has not made a final ruling of the July 2019 proposed new codes

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Page 28: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Investment Thesis

• Strong leadership positions across a range of revolutionary medical technologies • Cancer Detection• Cancer Therapy

• Uniquely positioned to capitalize on explosive growth in AI

• Established installed base

• Operating in substantial, growing addressable markets

• Significant opportunity to expand IORT applications globally

• Promising R&D pipeline with strong potential for expansion of 2 core technologies

• Promising reimbursement landscape aligned with value based care and drive to quality of quantity of care

• Motivated employees driven to deliver future wins

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A global medical technology leader providing innovative cancer detection and therapy solutions.

Page 29: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Appendix

Page 30: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

The Power of AI in Mammography Reading

4-mm spiculated mass detected by ProFound AI

Without ProFound AI: 6 of 24 radiologists detected cancer

With ProFound AI: 18 of 24 radiologists detected cancer (3-fold increase)

ProFound AI found it 100% of the time.

ProFound AI is CE Mark Approved & Health Canada Licensed. U.S. FDA Cleared December 2018. 30

Page 31: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Financial Highlights – YTD Q4 2019 vs 2018 Revenue

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• Two scalable business segments• Total revenue -> 22% increase• Detection segment revenues are growing

• Detection revenue -> 32% increase

• Stable revenue mix• Service revenue ->37% of total revenue• Product revenue -> 51% increase

13,111

19,766

12,510 11,574

0

5,000

10,000

15,000

20,000

25,000

Q4-18 Q4-19

(00

0's

)

Revenue by Type

Product

Service

16,864

22,319

8,757 9,021

-

5,000

10,000

15,000

20,000

25,000

Q4-18 Q4-19

(00

0's

)

Revenue by Segment

Detection

Therapy

Page 32: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

Financial Highlights – Quarter ended Q4 2019

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Attractive gross margins

• Q4 ‘19 YTD Gross Margin → 77%• Detection (AI Business) Margin → 83%• Therapy Margin → 62%

Sufficient capital • Cash and cash equivalents as of 12/31/19 = $15.3M

Debt

• Term Loan: $4.2M (Prime Rate)

• Convertible Debt: $7.0M Principal value (5% coupon, $4.00 conversion price, matures 12/21/2021) , Conversion forced during February 2020

Shares Outstanding • 19.5M Common Shares

Page 33: iCAD Corporate PresentationCertain statements contained in this presentation constitute “forward-looking statements”within the meaning of the Private Securities Litigation Reform

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